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Descriptive statistics were calculated for each of the baseline, primary and secondary outcome measures.
All patients will then be asked to complete a set of questionnaires that assess the baseline primary and secondary outcomes via the web (see Table 1).
Global functional performance at baseline also had a stronger correlation with follow-up physical disability than did the baseline number of tender, swollen, or deformed joints, or the baseline primary disability scales, MHAQ, SF36 PF, or Steinbrocker class.
Immunomagnetic selection of DTC was performed at the time of diagnosis, and by applying previously acquired ex vivo sunitinib inhibition profiles from the baseline primary tumor biopsies [ 8], the association between the tumor kinome and early systemic dissemination in terms of DTC status was studied.
The sample for the current analyses was comparable to that of the HRQOL analysis for the REVEAL trial [ 30] and included all randomized patients who had completed the baseline primary HRQOL assessment (based on the DLQI and SF-36) and at least one follow-up assessment within 16 weeks of study entry.
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29 The number of baseline primary PI mutations, as identified by the IAS-USA had minimal effect on virologic outcomes, as patients with 0 mutations in the TITAN trial achieved suppression in 84% (139/165) as did patients with ≥3 baseline mutations.
Second, all of the liver biopsies (baseline, primary endpoint) underwent a blinded central review by two independent expert liver histopathologists (RMB and SGH) at the one site, ensuring that only patients with 'definite' NASH were recruited to the trial and reducing intra/interassessor variability, which has previously been reported between trial sites.
Homogeneity of the initial distribution of baseline primary variables between groups was tested using a Fisher exact test for dichotomous variables and Student t test for continuous variables.
Patients will be randomised to the intervention or control group after they have consented to participating in the study and after baseline primary and secondary measures have been collected.
T1 = first phase, baseline primary school measurements.
The primary objective of the HARMONY Study is to compare mean awake and 24 h ABP between the treatment and control arms at the 12-week post-baseline primary assessment period (figure 1).
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